510(k) K102072
K102072 is an FDA 510(k) premarket notification submitted by Memometal Technologies for the device "MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE)". The FDA issued a decision of Substantially Equivalent on Nov 3, 2010. The device falls under product code HTY (Pin, Fixation, Smooth), a Class II device regulated under 21 CFR 888.3040. Memometal Technologies has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 2010
- Date Received
- Jul 23, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pin, Fixation, Smooth
- Device Class
- Class II
- Regulation Number
- 888.3040
- Review Panel
- OR
- Submission Type
- 510(k)